Ebola treatment raises ethical issues

Should experimental drug be made more widely available?

An ambulance transporting Nancy Writebol, an American missionary stricken with Ebola, arrives at Emory University Hospital, Tuesday, Aug. 5, 2014, in Atlanta. Writebol is expected to be admitted to Emory University Hospital on Tuesday, where she will join another U.S. aid worker, Dr. Kent Brantly, in a special isolation unit. (AP Photo/David Goldman)
The Associated Press

An ambulance transporting Nancy Writebol, an American missionary stricken with Ebola, arrives at Emory University Hospital, Tuesday, Aug. 5, 2014, in Atlanta. Writebol is expected to be admitted to Emory University Hospital on Tuesday, where she will join another U.S. aid worker, Dr. Kent Brantly, in a special isolation unit. (AP Photo/David Goldman)

This Aug. 5, 2014 photo shows the entrance to Kentucky Bioprocessing in Owensboro, Ky. Kentucky Bioprocessing has the ability to be a supplier of ZMapp, a drug aimed at boosting the immune system's efforts to fight off Ebola and is made from antibodies produced by lab animals exposed to parts of the virus. (AP Photo/Messenger-Inquirer, Jenny Sevcik)The Associated Press

+Read Caption

This Aug. 5, 2014 photo shows the entrance to Kentucky Bioprocessing in Owensboro, Ky. Kentucky Bioprocessing has the ability to be a supplier of ZMapp, a drug aimed at boosting the immune system's efforts to fight off Ebola and is made from antibodies produced by lab animals exposed to parts of the virus. (AP Photo/Messenger-Inquirer, Jenny Sevcik)

The emergency treatment of two Ebola-infected American health workers with an experimental drug developed by a San Diego company is raising thorny ethical and practical questions about what to do for others stricken with the disease.

Patients, government officials, health workers and social commentators in West Africa are openly calling for wider availability of the serum, even though it hasn’t been proven yet through clinical trials that it works.

In a statement, three leading Ebola experts, including Peter Piot, who helped discover the virus in 1976, said, “It is highly likely that if Ebola were now spreading in Western countries, public health authorities would give at-risk patients access to experimental drugs or vaccines.”

Related

A headline on a Washington Post website blog put it more bluntly: “Why do two white Americans get the Ebola serum while hundreds of Africans die?”

The World Health Organization announced Wednesday it would convene a panel of medical ethicists early next week to explore the use of experimental drugs in combating an outbreak that has infected more than 1,700 people and killed more than 930 in Guinea, Sierra Leone, Liberia and Nigeria.

“We have a disease with a high fatality rate without any proven treatment or vaccine,” Dr. Marie-Paule Kieny, a WHO administrator, said in a statement. “We need to ask the medical ethicists to give us guidance on what the responsible thing to do is.”

Yes
53% (17)

No
47% (15)

32 total votes.

Michael Kalichman, director of the Center for Ethics in Science and Technology at UC San Diego, said what’s likely to be foremost in the panel members’ minds is a simple principle: “Until you’ve done the research, you don’t know whether something is safe or effective.”

He noted that although the two American health workers, Kent Brantly and Nancy Writebol, appear to be getting better after receiving doses of the ZMapp serum, it’s not clear whether the medicine is responsible. Before they took it, it had never been tried on humans, only monkeys.

Ebola is often, but not always, deadly. The current fatality rate in West Africa is about 60 percent. It could turn out, in some people, that ZMapp is more toxic than the disease. That’s why the usual process for getting new drugs approved in the United States is so lengthy and expensive.

Robert Bohrer, a law professor and specialist in bioethics at California Western School of Law, said because ZMapp has never been tested on humans, “We have a limited ability to estimate the risks. However, we do have a clear understanding of the risk of this particular disease, and that could make it easier to justify experimentation.”

And he said there is evidence of potential benefit in the tests done on monkeys, and in the broader understanding of the way antibodies work in other drugs.

“The real problem,” he said, “is going to be in deciding who gets the drug.”

Ramping up production

ZMapp is made by Kentucky BioProcessing LLC, using a mixture of three antibodies created by Mapp Biopharmaceutical, the San Diego company. The antibodies recognize the Ebola virus and attach themselves to infected cells so the immune system can destroy them.

Making the drug involves growing the antibodies in tobacco plants and then purifying them, a slow process. David Howard, a spokesman for Kentucky BioProcessing, said the company is ramping up production, but it will be months before much of the serum can be produced.

He said “a very limited amount” has been manufactured so far. He declined to say how much remained after three vials of the drug were used to treat the American patients.

As the company produces more of the drug cocktail, he said, researchers will begin human trials later this year to test its safety and effectiveness against Ebola.

Kevin Whaley, CEO of Mapp Biopharmaceutical, said in an email Wednesday that the company had no comment on efforts to accelerate production of the serum.

For both companies, there are ethical issues, and liability concerns, associated with making the drug available before it’s been fully vetted. There will also be questions about what the drug will cost, and who will pay for it.

Howard declined to say how much ZMapp the company aims to manufacture in coming months, or what the cost per vial is.

“I do not know in terms of dollar figures,” Howard said. “Obviously, it’s an experimental drug, so I do not know any costs associated with it that would not be proprietary.”

If only a limited supply of the drug is available, who should get it? Children? Those without any underlying medical problems? Those who have had the disease the longest, or the shortest?

In typical drug trials, scientists try to minimize the variables to better understand how the medicine is working. That might not be possible considering the mounting urgency of the Ebola outbreak.

“This is a situation where some patients will say, ‘I don’t care how sure you are whether the drug works, I want to try it anyway,’” said Kalichman, the UCSD ethicist. “The researchers will face the hard personal and moral decision of someone pleading for help, but if you give it just to whoever comes to the door, you won’t learn enough to know whether it’s safe and effective.”